Recall Z-0364-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
| Date | Nov 15, 2010 (initiated Jun 1, 2010) |
| Status | Terminated |
| Reason | Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated to a patient record. |
| Root cause | Software design |
| Action | Clients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software. |
| Quantity | 40 |
| Distribution | Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.